(77 days)
No
The document describes a dental implant system and its components, focusing on materials, intended use, and mechanical performance testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of these technologies.
Yes
The device is described as "intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations..., It is used to restore a patient's chewing function." This directly indicates it is intended to treat a condition (edentulism) and restore a bodily function (chewing), which aligns with the definition of a therapeutic device.
No
The device is described as an implant system for prosthetic support and restoring chewing function, not for diagnosing conditions.
No
The device description clearly outlines physical components made of titanium and titanium alloy, intended for surgical implantation. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the ST Internal Implant System is a surgically placed device intended to provide support for dental restorations in the mouth. It is used to restore chewing function.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, detect diseases, or provide any diagnostic information about a patient's health based on in vitro testing.
The device is a dental implant system, which is a type of medical device used for surgical implantation and prosthetic support.
N/A
Intended Use / Indications for Use
The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The ST Internal Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The abutment is a superstructure of a dental implant system which is attached to the implants made of Ti-6A1-4V ELI with the surface treated by anodizing method(except healing and temporary abutment). The ST Internal Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function.
The system is consisted of the following components: ST Internal Fixture, EZ Post Abutment, Solid Abutment, Angled Abutment, Milling Abutment, Cover Screw, Healing Abutment, Temporary Abutment, and Abutment Screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility: The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993- 1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The additional biocompatibility testing is not required since the ST Internal Implant System has same material composition, manufacturing process and patient contacting parts as predicate device, AnyRidge Octa 1 Implant System (K182448) for fixtures(ASTM F67) and abutments(ASTM F136).
Modified Surface Treatment: The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff'. The ST Internal Implant System has same surface treatment and manufacturing process as predicate device, AnyRidge Octa 1 Implant System(K182448) for the surface treatment of S.L.A(Fixtures).
Pyrogen and Endotoxin Test: The endotoxin testing will be conducted on every batch for the subject device in accordance with 'Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers'.
Sterilization validating and Shelf Life: Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10-6). The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 year shelf life.
Performance (Physical Properties) Test: The following bench tests have been performed in accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of the subject devices and the test results met the pre-set criteria:
- Static compression-strength test
- Fatigue test
Results indicated that the subject device is better able to withstand the fatigue and loading compared to the predicate device, despite minor differences in size and features. The differences are minor and have been shown not to impact substantial equivalence.
No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2019
Megagen Implant Co. Ltd YouJung Kim Chief Researcher 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu. 42921 REPUBLIC OF KOREA
Re: K192347
Trade/Device Name: ST Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 14, 2019 Received: August 29, 2019
Dear YouJung Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192347
Device Name ST Internal Implant System
Indications for Use (Describe)
The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
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3
510(k) Summary (K192347)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: November 13, 2019
1.
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
YouJung Kim MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: +82-53-222-2985 Fax: +82-53-289-3420 Email: rnd ra4@imegagen.com
3. Device
| ■ Trade Name: | ST Internal Implant System | |
|---|---|---|
| ■ Common Name: | Endosseous Dental Implant | |
| ■ Classification Name: | Implant, Endosseous, Root-Form | |
| ■ Classification Product Code: | DZE | |
| ■ Subsequent Product Code: | NHA | |
| ■ Classification regulation: | Class II, 21 CFR 872.3640 |
4. Predicate Device:
- " Primary Predicate Device: K182448 – AnyRidge Octa 1 Implant System
- . Reference Devices: K123988 – AnyOne Internal Implant System
4
5. Description:
The ST Internal Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The abutment is a superstructure of a dental implant system which is attached to the implants made of Ti-6A1-4V ELI with the surface treated by anodizing method(except healing and temporary abutment). The ST Internal Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function.
The system is consisted of the following components.
| Component | Content |
|---|---|
| ST Internal | |
| Fixture | Description |
| ST Internal Fixtures are made of titanium. The osseointegrated implant fixtures placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The dental implants which used in conjunction with other prosthetic restore lost chewing ability, improve appearance. | |
| Material Composition | |
| CP Ti Grade 4 | |
| Dimension | |
| (Diameter &Length) | |
| Ø 3.70 x 8.50, 10.00, 11.50, 13.00, 15.00 mm | |
| Ø 4.20 x 7.00, 8.50, 10.00, 11.50, 13.00, 15.00 mm | |
| Ø 4.60 x 7.00, 8.50, 10.00, 11.50, 13.00, 15.00 mm | |
| Ø 5.10 x 7.00, 8.50, 10.00, 11.50, 13.00, 15.00 mm | |
| Ø 6.00 x 7.00, 8.50, 10.00, 11.50, 13.00 mm | |
| Ø 6.80 x 7.00, 8.50, 10.00, 11.50, 13.00 mm | |
| EZ Post | |
| Abutment | Description |
| EZ Post Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis. | |
| Material Composition | |
| Ti-6A1-4V ELI | |
| Dimension | |
| (Diameter &Length) | |
| Ø 4.60 x 5.50, 7.00 mm | |
| Ø 5.00 x 4.00, 5.50, 7.00 mm | |
| Ø 6.00 x 4.00, 5.50, 7.00 mm | |
| Ø 7.00 x 5.50 mm | |
| Angulation | |
| 0° | |
| Solid | |
| Abutment | Description |
| Solid Abutment is used in conjunction with fixture to provide support for final prosthesis, and used in cement retained type prosthesis only. | |
| Material Composition | |
| Ti-6A1-4V ELI | |
| Dimension | |
| (Diameter &Length) | |
| Ø 4.00 x 10.00, 11.00, 11.50, 12.00, 12.50, 13.00, 13.50, 14.00, | |
| 14.50, 15.00, 15.50, 16.00, 17.00 mm | |
| Ø 4.00 x 10.40, 11.40, 11.90, 12.40, 12.90, 13.40, 13.90, 14.40, | |
| 14.90, 15.40, 15.90, 16.40, 17.40 mm | |
| Ø 4.60 x 10.00, 11.00, 11.50, 12.00, 12.50, 13.00, 13.50, 14.00, | |
| 14.50, 15.00, 15.50, 16.00, 17.00 mm | |
| Ø 4.60 x 10.40, 11.40, 11.90, 12.40, 12.90, 13.40, 13.90, 14.40, | |
| 14.90, 15.40, 15.90, 16.40, 17.40 mm | |
| Ø 5.00 x 10.40, 11.40, 11.9কিন্তo, 12.40, 12.90, 13.40, 13.90, 14.40, | |
| 14.90, 15.40, 15.90, 16.40, 17.40 mm | |
| Ø 6.00 x 10.40, 11.40, 11.90, 12.40, 12.90, 13.40, 13.90, 14.40, | |
| 14.90, 15.40, 15.90, 16.40, 17.40 mm | |
| Ø 7.00 x 11.90, 12.90, 13.90, 14.90, 15.90 mm | |
| Angulation | |
| 0° | |
| Angled | |
| Abutment | Description |
| Angled Abutment is used for correcting the prosthetic angulation of implant. | |
| Material Composition | |
| Ti-6A1-4V ELI | |
| Dimension | |
| (Diameter &Length) | |
| Ø 4.30 x 12.60, 14.60 mm | |
| Ø 4.50 x 12.50, 14.50 mm | |
| Ø 5.00 x 12.50, 14.50 mm | |
| Ø 6.00 x 12.50, 14.50 mm | |
| Angulation | |
| 17° |
5
| Milling
Abutment | Description | Milling Abutment is used in conjunction with fixture to provide
support for cement and screw retained type final prosthesis and used
for establishing an adequate safety margin from occlusal line by hand
milling of the post part. |
|-----------------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Material Composition | Ti-6A1-4V ELI |
| | Dimension
(Diameter &Length) | Ø 4.00 x 14.50, 14.60 mm
Ø 5.00 x 12.00, 14.50 mm
Ø 6.00 x 14.50 mm
Ø 7.00 x 14.50 mm |
| | Angulation | 0° |
| Cover
Screw | Description | Cover Screw is used for protecting the inner structure of a fixture and
the exposed fixture platform after fixture placement. |
| | Material Composition | Ti-6A1-4V ELI |
| | Dimension
(Diameter &Length) | Ø 3.10 x 5.30mm
Ø 3.60 x 5.90mm |
| | Angulation | 0° |
| Healing
Abutment | Description | Healing Abutment helps to form suitable emergence profile during
period of gingival healing. |
| | Material Composition | Ti-6A1-4V ELI |
| | Dimension
(Diameter &Length) | Ø 4.30 x 7.50, 8.50, 8.60, 9.50, 9.60, 10.60, 11.50, 12.60, 13.50,
14.60 mm
Ø 4.80 x 7.50, 8.50, 8.60, 9.50, 9.60, 10.60, 11.50, 12.60, 13.50,
14.60 mm
Ø 5.30 x 8.60, 9.60, 10.60, 12.60, 14.60 mm
Ø 6.30 x 8.60, 9.60, 10.60, 12.60, 14.60 mm
Ø 7.30 x 8.60, 9.60, 10.60, 12.60, 14.60 mm |
| | Angulation | 0° |
| | | |
| Temporary
Abutment | Description | Temporary Abutment is used in conjunction with fixture to provide
support for provisional restoration. Temporary Abutment has knurled
surface on the top part, which allows for better retention of resin or
wax. |
| | Material Composition | Ti-6A1-4V ELI |
| | Dimension
(Diameter &Length) | Ø 4.00 x 13.60, 15.60 mm
Ø 4.50 x 13.50, 15.50 mm |
| | Angulation | 0° |
| Abutment
Screw | Description | Abutment Screw is used for securing the abutment to the endosseous
implant. |
| | Material Composition | Ti-6A1-4V ELI |
| | Dimension
(Diameter &Length) | Ø 2.15 x 10.20 mm
Ø 2.35 x 8.40 mm |
6. Indication for use:
The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
6
7. Basis for Substantial Equivalence
The ST Internal Implant System is substantially equivalent to the predicate device in terms of indication for use, technical characteristics and function. They are material and have similar design. The size range and design of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence.
In order to demonstrate the difference in design does not raise any new issues in safety and effectiveness, each performance test on the subject and predicate device have been performed to figure out the physical property(e.g. fatigue limit) with combination of the fixture and the angled abutment, in consideration of the worst case according to "ISO 14801:2007" and "Section 8 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment". The test result shows that the subject device is better able to withstand the fatigue and loading.
Based on the detailed comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate devices.
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) | |||
| Number | Not yet | K182448 | K123988 |
| Device Name | ST Internal Fixture | AnyRidge Octa 1 Implant System | AnyOne Internal Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications | |||
| for Use | |||
| Statement | The ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. | |||
| It is used to restore a patient's | |||
| chewing function. Smaller implants | |||
| (less than 6.0 mm) are dedicated for | |||
| immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region and are indicated for | |||
| delayed loading. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose of | |||
| providing prosthetic support for | |||
| dental restorations (Crown, bridges, | |||
| and overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's chewing | |||
| function in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region. | The AnyOne Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular molar areas for the | |||
| purpose providing prosthetic support | |||
| for dental restorations (Crown, | |||
| bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. | |||
| It is used to restore a patient's | |||
| chewing function. Smaller implants | |||
| (less than 6.0 mm) are dedicated for | |||
| immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region and are indicated | |||
| for delayed loading. | |||
| Appearance | |||
| Material | CP Ti Grade 4 | CP Ti Grade 4 | CP Ti Grade 4 |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Diameter(Ø) | 3.7, 4.2, 4.6, 5.1, 6.0, 6.8mm | 3.6, 4.0, 4.4, 4.7, 4.8, 5.0, | |
| 5.5mm | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8 | ||
| 7.3, 7.8, 8.3 mm | |||
| Length (mm) | 7.0, 8.5, 10, 11.5, 13, 15mm | 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, | |
| 17.2mm | 7.0, 8.0, 9.5, 11.0, 12.5, | ||
| 14.5mm | |||
| Surface | Sand-blasted, Large grit, Acid- | Sand-blasted, Large grit, Acid- | Sand-blasted, Large grit, Acid- |
| treatment | etched (S.L.A) | etched (S.L.A) | etched (S.L.A) |
| Implant-to- | |||
| abutment | |||
| connection | Hex | Octa | Hex |
| Feature | - Submerged implant |
- Tapered body
- cutting edge with selftapping
- 0.7, 0.8mm thread pitch | - Submerged implant
- Tapered body
- cutting edge with self-tapping
- 0.8mm thread pitch | - Submerged implant
- Tapered body
- cutting edge with self-tapping
- 0.8mm thread pitch |
7
| Principle of
operation | This product is a tapered body
fixture which is inserted in the
alveolar bone.
It replaces the functions of the
missing teeth as a dental implant
fixture. | This product is a tapered body
fixture which is inserted in the
alveolar bone.
It replaces the functions of the
missing teeth as a dental implant
fixture. | This product is a tapered body
fixture which is inserted in the
alveolar bone.
It replaces the functions of the
missing teeth as a dental implant
fixture. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shelf Life | 5 Years | 5 Years | 5 Years |
| Substantial Equivalence Discussion | | | |
1. Similarities
- The subject device has the same characteristic for the following compared to the predicate/reference devices. Manufacturer, Indication for use, Material, Sterilization Method, Surface treatment, Implant-to-abutment
- connection, Principle of operation and Shelf life
Differences 2.
- The subject device has the different characteristic for the following compared to the predicate/reference devices. Diameter, Length and Feature -
3. Discussion for difference
- Diameter:
The diameters of the subject device are slightly different with predicate device however the subject device lies within the range of reference device excepting for diameter 3.7 can be covered with diameter 3.6 included in predicate device.
There is a minimal difference in the diameter but the substantial equivalence was demonstrated by the fatigue test stated below.
- Feature: -
The subject device has a same feature as a predicate/reference device excluding a thread pitch. A thread pitch(0.7mm) is added in subject device, however there is a just 0.1mm difference in screw pitch between 0.7mm and 0.8mm. It does not cause a matter in substantial equivalence since the size difference is very minor.
: In order to demonstrate the differences do not raise an issue in substantial equivalence, each fatigue test on the subject and predicate device have been performed to figure out the physical property(e.g. fatigue limit), with combination of the fixture and the angled abutment, in consideration of the worst case according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment". The test result shows that the subject device is better able to withstand the fatigue and loading in spite of the size and feature differences.
In conclusion, the subject device is substantially equivalent to the predicate device since the differences are minor and theses have been identified via the fatigue test the differences do not impact substantial equivalence.
8
EZ Post Abutment
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) | |||
| Number | Not yet | K182448 | K123988 |
| Device Name | EZ Post Abutment | ||
| for ST Internal Implant System | EZ Post Abutment | ||
| AnyRidge Octa 1 Implant System | EZ Post Abutment | ||
| for AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. | |||
| It is used to restore a patient's | |||
| chewing function. Smaller implants | |||
| (less than 6.0 mm) are dedicated for | |||
| immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region and are indicated for | |||
| delayed loading. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose of | |||
| providing prosthetic support for | |||
| dental restorations (Crown, bridges, | |||
| and overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's chewing | |||
| function in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region. | The AnyOne™ Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular molar areas for the | |||
| purpose providing prosthetic support | |||
| for dental restorations (Crown, | |||
| bridges, and overdentures) in | |||
| partially or fully edentulous | |||
| individuals. It is used to restore a | |||
| patient's chewing function. Smaller | |||
| implants (less than Ø6.0 mm) are | |||
| dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed | |||
| loading. | |||
| Appearance | |||
| Diameter | 4.6, 5.0, 6.0, 7.0mm | 4.0, 5.0, 6.0, 7.0mm | 4.5, 5.5, 6.5 mm |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5mm |
| Gingival | |||
| Height | 1.0, 2.0, 3.0, 4.0, 5.0mm | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.0, 1.5, 2.5, 3.5, 4.5, 5.5mm |
| Connection | |||
| Interface | Hex, Non-Hex | Octa, non-octa | Hex, Non-Hex |
| Surface | |||
| treatment | Anodizing | Anodizing | Anodizing |
| Sterilization | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | |||
| Angulation | 0° | 0° | 0° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle of | |||
| operation | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. | |||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the following compared to the predicate/reference devices.
- Manufacturer, Indication for use, Post Height, Connection Interface, Surface Treatment, Sterilization Method, Angulation, -Material, and Principle of operation
2. Differences
-
The subject device has the different characteristic for the following compared to the predicate/reference devices.
-
Diameter, Gingival Height -
Discussion for difference 3.
Diameter
The diameter of the subject device is slightly larger than predicate/reference device by addition of diameter 4.6mm in subject device however it does not cause a matter in substantial equivalence since the subject device lies within the range of the predicate device and the size difference is very minor.
- Gingival Height: -
The gingival height range of the subject device is slightly different with predicate device however these differences can be covered by reference devices. Also, the variety of the size can be possible to operate more precise treatment to meet each patient's condition and does not cause a matter in substantial equivalence since the size difference is very minor.
9
Solid Abutment
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | Not yet | K123988 |
| Device Name | Solid Abutment | |
| for ST Internal Implant System | Solid Abutment | |
| for AnyOne Internal Implant System | ||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | ||
| Use Statement | The ST Internal Implant System is intended to be | |
| surgically placed in the maxillary or mandibular arches | ||
| for the purpose providing prosthetic support for dental | ||
| restorations (Crown, bridges, and overdentures) in | ||
| partially or fully edentulous individuals. | ||
| It is used to restore a patient's chewing function. | ||
| Smaller implants (less than 6.0 mm) are dedicated for | ||
| immediate loading when good primary stability is | ||
| achieved and with appropriate occlusal loading. Larger | ||
| implants are dedicated for the molar region and are | ||
| indicated for delayed loading. | The AnyOne™ Internal Implant System is intended to | |
| be surgically placed in the maxillary or mandibular | ||
| molar areas for the purpose providing prosthetic support | ||
| for dental restorations (Crown, bridges, and | ||
| overdentures) in partially or fully edentulous | ||
| individuals. It is used to restore a patient's chewing | ||
| function. Smaller implants (less than Ø6.0 mm) are | ||
| dedicated for immediate loading when good primary | ||
| stability is achieved and with appropriate occlusal | ||
| loading. Larger implants are dedicated for the molar | ||
| region and are indicated for delayed | ||
| loading. | ||
| Appearance | Image: Subject Device Appearance | Image: Predicate Device Appearance |
| Diameter | 4.0, 4.6, 5.0, 6.0, 7.0mm | 4.0, 4.5, 5.5, 6.5mm |
| Post Height | 4.0, 5.5, 7.0mm | 4.0, 5.5, 7.0mm |
| Gingival | ||
| Height | 1.0, 2.0, 3.0, 4.0, 5.0mm | 1.0, 1.5 2.5, 3.5, 4.5, 5.5mm |
| Connection | ||
| Interface | Hex | Hex |
| Surface | ||
| treatment | Anodizing | Anodizing |
| Sterilization | Non-sterile; intended for terminal sterilization via | |
| moist heat(autoclave) | Non-sterile; intended for terminal sterilization via moist | |
| heat(autoclave) | ||
| Angulation | 0° | 0° |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
| Principle of | ||
| operation | This product is a superstructure which is connects with | |
| the fixtures using the Abutment Screw. It replaces the | ||
| functions of the missing teeth as a dental abutment. | This product is a superstructure which is connects with | |
| the fixtures using the Abutment Screw. It replaces the | ||
| functions of the missing teeth as a dental abutment. | ||
| Substantial Equivalence Discussion | ||
| 1. Similarities | ||
| The subject device has the same characteristic for the following compared to the predicate/reference devices. |
- Manufacturer, Indication for use, Post Height, Connection Interface, Surface Treatment, Sterilization Method, Angulation,
Material and Principle of operation | | |
| 2. Differences
The subject device has the different characteristic for the following compared to the predicate/reference devices. - Diameter and Gingival Height | | |
| 3. Discussion for difference - Diameter
The diameter of the subject device is slightly different with predicate device however it does not cause a matter in
substantial equivalence since the size difference is very minor. - Gingival Height:
The gingival height range of the subject device is slightly wider than predicate device by the addition of a gingival
height(1.0mm) in subject device however these differences can be covered by reference device. Also, the variety of the
size can be possible to operate more precise treatment to meet each patient's condition and does not cause a matter in
substantial equivalence since the size difference is very minor. | | |
10
Angled Abutment
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) | |||
| Number | Not yet | K182448 | K123988 |
| Device Name | Angled Abutment | ||
| for ST Internal System | Angled Abutment | ||
| for AnyRidge Octa 1 Implant System | Angled Abutment | ||
| for AnyOne™ Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications | |||
| for Use | |||
| Statement | The ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. | |||
| It is used to restore a patient's | |||
| chewing function. Smaller implants | |||
| (less than 6.0 mm) are dedicated for | |||
| immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region and are indicated for | |||
| delayed loading. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose of | |||
| providing prosthetic support for | |||
| dental restorations (Crown, bridges, | |||
| and overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's chewing | |||
| function in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region. | The AnyOne™ Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or mandibular | |||
| molar areas for the purpose providing | |||
| prosthetic | |||
| support | |||
| for | |||
| dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function. | |||
| Smaller implants (less than Ø6.0 | |||
| mm) are dedicated for immediate | |||
| loading when good primary stability | |||
| is achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed loading. | |||
| Appearance | Image: angled abutment | Image: angled abutment | Image: angled abutment |
| Diameter | 4.3, 4.5, 5.0, 6.0mm | 3.85, 4.2, 5.0, 6.0mm | 4.5, 5.5mm |
| Post Height | 8.0mm | 7.0m | 7.0m |
| Gingival | |||
| Height | 2.0, 4.0mm | 1.8, 2.8, 3.8, 4.8mm | 2.5, 4.5mm |
| Connection | |||
| Interface | Hex, Hex-E, Non-Hex | Hex, Non-Hex | Hex, Non-Hex |
| Surface | |||
| treatment | Anodizing | Anodizing | Anodizing |
| Sterilization | Non-sterile; intended for terminal | ||
| sterilization | |||
| via | |||
| moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization | |||
| via | |||
| moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization | |||
| via | |||
| moist | |||
| heat(autoclave) | |||
| Angulation | 17° | 15°, 25° | 15°, 25° |
| Material | Ti-6A1-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle of | |||
| operation | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. | |||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the following compared to the predicate/reference devices.
Manufacturer, Indication for use, Gingival Height, Surface Treatment, Sterilization Method, Material and Principle of । operation
2. Differences
- The subject device has the different characteristic for the following compared to the predicate devices.
- Diameter, Post Height, Connection Interface and Angulation
3. Discussion for difference
-
Diameter: l
The diameter of the subject device is slightly different with predicate/reference devices however it does not cause a matter in substantial equivalence since the subject device lies within the range of the size difference is very minor. -
Post Height: -
The post height is just 1mm longer than predicate/reference devices, however it does not cause a matter in substantial equivalence since the size difference is very minor. -
-Connection Interface
- Connection interface can be covered by predicate/reference devices.
The non-hex type is capable of operating wide range of treatment to meet each patient's condition since the non-hex type is
11
free from the limit of the angle and direction unlike hex and hex-e type. The multiple predicate devices that have connection interface of non-hex type are already presented in other component comparison charts.
Angulation
The angulation of subject device is different with predicate/reference devices however the substantial equivalence have been demonstrated via the fatigue test carried out for the subject & predicate device both. The subject device(angled abutment) has been selected as the representative specimen under the consideration of worst case in accordance with 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The test result supports that the subject device is substantially equivalent to the predicate devices in spite of the angle differences and not affecting the substantial equivalence.
12
Milling Abutment
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | Not yet | K182448 | K123988 |
| Device Name | Milling Abutment | ||
| for ST Internal Implant System | Milling Abutment | ||
| for AnyRidge Octa 1 Implant System | Milling Abutment | ||
| for AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. | |||
| It is used to restore a patient's | |||
| chewing function. Smaller implants | |||
| (less than 6.0 mm) are dedicated for | |||
| immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region and are indicated for | |||
| delayed loading. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose of | |||
| providing prosthetic support for | |||
| dental restorations (Crown, bridges, | |||
| and overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's chewing | |||
| function in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region. | The AnyOne™ Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular molar areas for the | |||
| purpose providing prosthetic support | |||
| for dental restorations (Crown, | |||
| bridges, and overdentures) in | |||
| partially or fully edentulous | |||
| individuals. It is used to restore a | |||
| patient's chewing function. Smaller | |||
| implants (less than Ø6.0 mm) are | |||
| dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed loading. | |||
| Appearance | Image: gold colored abutment | Image: gold colored abutment | Image: silver colored abutment |
| Diameter | 4.0, 5.0, 6.0, 7.0mm | 6.0, 8.0mm | 4.0, 4.5, 5.5, 6.5mm |
| Post Height | 9.0, 10.5mm | 9.0mm | 9.0mm |
| Gingival | |||
| Height | 1.5, 3.0mm | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.5, 2.0, 2.5, 4.0mm |
| Connection | |||
| Interface | Hex | Octa, non-octa | Hex, Non-Hex |
| Surface | |||
| treatment | Anodizing | Anodizing | Anodizing |
| Sterilization | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | |||
| Angulation | 0° | 0° | 0° |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6Al-4V ELI |
| Principle of | |||
| operation | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. | This product is a superstructure | ||
| which is connects with the fixtures | |||
| using the Abutment Screw. It | |||
| replaces the functions of the missing | |||
| teeth as a dental abutment. |
Substantial Equivalence Discussion
1. Similarities
The subject device has the same characteristic for the following compared to the predicate/reference devices.
Manufacturer, Indication for use, Connection Interface, Surface Treatment, Sterilization Method, Angulation, Material and -Principle of operation
2. Differences
- The subject device has the different characteristic for the following compared to the predicate/reference devices.
- Diameter, Post Height and Gingival Height
Discussion for difference 3.
- Diameter: -
- The diameter of the subject device is slightly different with predicate/reference devices however it does not cause a matter in substantial equivalence since the subject device lies within the combined range of the predicate/reference device and the size difference is very minor.
- Post Height and Gingival Height: The post height range of the subject device is slightly different with predicate/reference device by the addition of a post height(10.5mm) in subject device. The variety of the size can be possible to operate more precise treatment to meet each patient's condition. The gingival height range of the subject device is slightly different with predicate/reference device but the subject device lies within the range of the predicate/reference device. Also, these differences do not cause a matter in substantial equivalence since the size difference is very minor.
13
Cover Screw
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) | ||
| Number | Not yet | K182448 |
| Device Name | Cover Screw | |
| for ST Internal Implant System | Cover Screw | |
| for AnyRidge Octa 1 Implant System | ||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications | ||
| for Use | ||
| Statement | The ST Internal Implant System is intended to be | |
| surgically placed in the maxillary or mandibular | ||
| arches for the purpose providing prosthetic | ||
| support for dental restorations (Crown, bridges, | ||
| and overdentures) in partially or fully edentulous | ||
| individuals. | ||
| It is used to restore a patient's chewing function. | ||
| Smaller implants (less than 6.0 mm) are dedicated | ||
| for immediate loading when good primary | ||
| stability is achieved and with appropriate occlusal | ||
| loading. Larger implants are dedicated for the | ||
| molar region and are indicated for delayed | ||
| loading. | The AnyRidge Octa 1 Implant System is intended | |
| to be surgically placed in the maxillary or | ||
| mandibular arches for the purpose of providing | ||
| prosthetic support for dental restorations (Crown, | ||
| bridges, and overdentures) in partially or fully | ||
| edentulous individuals. It is used to restore a | ||
| patient's chewing function in the following | ||
| situations and with the clinicalprotocols: | ||
| -Delayed loading. | ||
| -Immediate loading when good primary stability | ||
| is achieved and with appropriate occlusal loading. | ||
| Larger implants are dedicated for the molar | ||
| region. | ||
| Appearance | Image: purple implant | Image: yellow implant |
| Diameter | 3.1, 3.6mm | 3.0, 3.7, 5.0, 6.0mm |
| Gingival | ||
| Height | 0.4mm | 0.5, 1.0mm |
| Connection | ||
| Interface | Internal Conical connection | Internal Conical connection |
| Surface | ||
| treatment | Anodizing | Anodizing |
| Sterilization | Gamma sterilization | Gamma sterilization |
| Angulation | 0° | 0° |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
| Principle of | ||
| operation | Cover Screw is used for protecting the inner | |
| structure of a fixture, and exposed fixture platform | ||
| after fixture placement. | Cover Screw is used for protecting the inner | |
| structure of a fixture, and exposed fixture platform | ||
| after fixture placement. | ||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the following compared to the predicate devices.
Manufacturer, Indication for use, Connection Interface, Surface Treatment, Sterilization Method, Angulation, י Material and Principle of operation
2. Differences
י
The subject device has the different characteristic for the following compared to the predicate devices.
- Diameter and Gingival Height -
3. Discussion for difference
Diameter and Gingival Height
The diameter range of the subject device is slightly different with predicate devices however it does not cause a matter in substantial equivalence since the subject device lies within the range of the predicate devices. The gingival height range of the subject device is slightly shorter than predicate devices however the variety of the size can be possible to operate more precise treatment to meet each patient's condition. Also, these differences do not cause a matter in substantial equivalence since the size difference is very minor.
14
Healing Abutment
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | Not yet | K182448 | K123988 |
| Device Name | Healing Abutment | ||
| for ST Internal Implant System | Healing Abutment | ||
| for AnyRidge Octa 1 Implant System | Healing Abutment™ | ||
| for AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. | |||
| It is used to restore a patient's | |||
| chewing function. Smaller implants | |||
| (less than 6.0 mm) are dedicated for | |||
| immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region and are indicated for | |||
| delayed loading. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose of | |||
| providing prosthetic support for | |||
| dental restorations (Crown, bridges, | |||
| and overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's chewing | |||
| function in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | The AnyOne™ Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular molar areas for the | |||
| purpose providing prosthetic support | |||
| for dental restorations (Crown, | |||
| bridges, and overdentures) in | |||
| partially or fully edentulous | |||
| individuals. It is used to restore a | |||
| patient's chewing function. Smaller | |||
| implants (less than Ø6.0 mm) are | |||
| dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed | |||
| loading. | |||
| Appearance | Image: Subject Device Appearance | Image: Predicate Device Appearance | Image: Reference Device Appearance |
| Diameter | 4.3, 4.8, 5.3, 6.3, 7.3mm | 3.2, 4.2, 5.2, 6.2mm | 4.2, 4.7, 5.7, 6.7, 7.7, 8.7, 9.7mm |
| Gingival | |||
| Height | 3.0, 4.0, 5.0, 7.0, 9.0mm | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, | |
| 9.5mm | 2.3, 2.8, 3.8, 4.8, 5.8, 6.8mm | ||
| Connection | |||
| Interface | Internal Conical connection | Internal Conical connection | Internal Conical connection |
| Surface | |||
| treatment | Machined | Anodizing | Machined |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Angulation | 0° | 0° | 0° |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
| Principle of | |||
| operation | The Healing Abutment is fastened | ||
| into the female screw of dental | |||
| implant and support the gingival | |||
| shaping. | The Healing Abutment is fastened | ||
| into the female screw of dental | |||
| implant and support the gingival | |||
| shaping. | The Healing Abutment is fastened | ||
| into the female screw of dental | |||
| implant and support the gingival | |||
| shaping. | |||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the following compared to the predicate/reference devices. Manufacturer, Indication for use, Connection Interface, Surface Treatment, Sterilization Method, Angulation, Material and Principle of operation
2. Differences
- The subject device has the different characteristic for the following compared to the predicate/reference devices.
- Diameter and Gingival Height
3. Discussion for difference
- Diameter and Gingival Height:
The diameter of the subject device is slightly different with predicate/reference devices however it does not cause a matter in substantial equivalence since the subject device lies within the combined range of the predicate/reference device. The gingival height range of the subject device is slightly different with predicate/reference device lies within the range of the predicate device. Also, these differences do not cause a matter in substantial equivalence since the size difference is very minor.
15
Temporary Abutment
| Subject Device | Predicate Device | Reference Device 2 | |
|---|---|---|---|
| 510(k) | |||
| Number | Not yet | K182448 | K123988 |
| Device Name | Temporary Abutment | ||
| for ST Internal Implant System | Temporary Abutment | ||
| for AnyRidge Octa 1 Implant System | Temporary Abutment | ||
| for AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. | |||
| It is used to restore a patient's | |||
| chewing function. Smaller implants | |||
| (less than 6.0 mm) are dedicated for | |||
| immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region and are indicated for | |||
| delayed loading. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose of | |||
| providing prosthetic support for | |||
| dental restorations (Crown, bridges, | |||
| and overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's chewing | |||
| function in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region. | The AnyOne™ Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular molar areas for the | |||
| purpose providing prosthetic support | |||
| for dental restorations (Crown, | |||
| bridges, and overdentures) in | |||
| partially or fully edentulous | |||
| individuals. It is used to restore a | |||
| patient's chewing function. Smaller | |||
| implants (less than Ø6.0 mm) are | |||
| dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Largerimplants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed loading. | |||
| Appearance | |||
| Diameter | 4.0, 4.5mm | 4.0, 5.0mm | 4.5mm |
| Post Height | 12mm | 10mm | 11mm |
| Gingival | |||
| Height | 1.0, 3.0mm | 2.0, 3.0mm | 1.0mm |
| Connection | |||
| Interface | Hex, Non-Hex | Octa, non-octa | Hex, Non-Hex |
| Surface | |||
| treatment | Machined | Anodizing | Machined |
| Sterilization | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | |||
| Angulation | 0° | 0° | 0° |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
| Principle of | |||
| operation | Temporary Abutment is used in | ||
| conjunction with fixture to provide | |||
| support for provisional restoration. | Temporary Abutment is used in | ||
| conjunction with fixture to provide | |||
| support for provisional restoration. | Temporary Abutment is used in | ||
| conjunction with fixture to provide | |||
| support for provisional restoration. | |||
| Substantial Equivalence Discussion |
Similarities 1.
The subject device has the same characteristic for the following compared to the predicate/reference devices. Manufacturer, Indication for use, Connection Interface, Surface Treatment, Sterilization Method, Angulation, Material and -
Principle of operation
2. Differences
The subject device has the different characteristic for the following compared to the predicate/reference devices. Diameter, Post Height and Gingival Height
Discussion for difference 3.
Diameter: -
The diameter of the subject device is slightly smaller than predicate device by addition of diameter 4.5mm in subject device however this difference can be covered by reference device. Also, it does not cause a matter in substantial equivalence since the size difference is veryminor.
- -Post Height and Gingival Height:
The post height is slightly longer than predicate/reference devices, however there is a just 1 mm difference between subject and reference device. The gingival height range of subject device is slightly wider than predicate device however one of the gingival heights(1.0mm) in subject device can be covered by reference device. The variety of the size can be possible to operate more precise treatment to meet each patient's condition and these differences do not cause a matter in substantial equivalence since the size difference is veryminor.
16
Abutment Screw
| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| 510(k) Number | Not yet | K182448 | K123988 |
| Device Name | Abutment Screw | ||
| for ST Internal Implant System | Abutment Screw | ||
| for AnyRidge Octa 1 Implant System | Abutment Screw | ||
| for AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. | |||
| It is used to restore a patient's | |||
| chewing function. Smaller implants | |||
| (less than 6.0 mm) are dedicated for | |||
| immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region and are indicated for delayed loading. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose of | |||
| providing prosthetic support for | |||
| dental restorations (Crown, bridges, | |||
| and overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function | |||
| in the following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for the | |||
| molar region. | The AnyOneTM Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or mandibular | |||
| molar areas for the purpose providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function. | |||
| Smaller implants (less than Ø6.0 mm) | |||
| are dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed loading. | |||
| Appearance | Image: Abutment screw | Image: Abutment screw | Image: Abutment screw |
| Diameter | 2.15, 2.35 mm | 2.2 mm | 2.3 mm |
| Total Height | 8.4, 10.2 mm | 7.9 | 9.9 mm |
| Connection | |||
| Interface | Internal Conical connection | Internal Conical connection | Internal Conical connection |
| Surface | |||
| treatment | Anodizing | Machined | Machined |
| Sterilization | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | |||
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
| Principle of | |||
| operation | Abutment screw is used for securing | ||
| the abutment to the endosseous | |||
| implant. | Abutment screw is used for securing | ||
| the abutment to the endosseous | |||
| implant. | Abutment screw is used for securing | ||
| the abutment to the endosseous | |||
| implant. | |||
| Substantial Equivalence Discussion |
1. Similarities
- The subject device has the same characteristic for the following compared to the predicate devices.
- Manufacturer, Indication for use, Connection Interface, Sterilization Method, Angulation, Material and Principle י of operation
2. Differences
-
The subject device has the different characteristic for the following compared to the predicate devices.
-
Diameter, Total Height and Surface treatment -
Discussion for difference 3.
- Diameter and Total Height:
- The diameter and total height range of the subject device is slightly different with predicate/reference device however it does not cause a matter in substantial equivalence since the size difference is very minor.
- Surface Treatment: -
- The other difference is in surface treatment but we already presented multiple predicate/reference devices for anodizing in the other component comparison charts.
17
8. Summary of Non-Clinical Testing
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993- 1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The additional biocompatibility testing is not required since the ST Internal Implant System has same material composition, manufacturing process and patient contacting parts as predicate device, AnyRidge Octa 1 Implant System (K182448) for fixtures(ASTM F67) and abutments(ASTM F136).
Modified Surface Treatment
The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff'.
The ST Internal Implant System has same surface treatment and manufacturing process as predicate device, AnyRidge Octa 1 Implant System(K182448) for the surface treatment of S.L.A(Fixtures).
Pyrogen and Endotoxin Test
The endotoxin testing will be conducted on every batch for the subject device in accordance with 'Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers'.
Sterilization validating and Shelf Life
Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10-6). The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 year shelf life.
Also, the following guidance documents were referred to:
- . Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- . Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Performance (Physical Properties) Test
The following bench tests have been performed in accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of the subject devices and the test results met the pre-set criteria.
- Static compression-strength test ●
- Fatigue test ●
Summary of Clinical Testing 9.
No clinical studies are submitted.
10. Conclusion
Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the ST Internal Implant System is substantially equivalent to the predicate device as herein.